PreventionPhase 4NCT03925740
MI and PreviDent Varnish on Non Cavitated Interproximal Lesions.
A Phase 4 study testing MI Varnish, PreviDent Varnish and 1.23% APF in people with Prevention, run by King Abdulaziz University at 1 site in Saudi Arabia.
Trial summary
Fluoride products are proven to be cost effective in preventing dental caries. Newer Fluoride products have been released in the market with different components that may have an impact on the clinical and radiographic outcome regarding incipient caries management. Read more about this study
- Who is it for?
- Ages 7 to 10 years
- Conditions the study is for
- Prevention
- What is being tested?
- MI Varnish, PreviDent Varnish and 1.23% APF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Jan 2019to 1 Sep 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patient is 7-10 mixed dentition
- Patients with any incipient non cavitated posterior proximal caries
- Patients with any incipient non cavitated anterior proximal cariesanterior
- ICDAS Score 1 or 2
Who cannot join
- Any patients with any serious chronic medical problem.
- caries that cross the dentin-enamel junction (DEJ) or enamel discontinuity
- history of proximal restorations
- history of resin infiltrate
- ICDAS score of proximal caries more than two clinically or radiographically.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
King Adbulaziz University Dental Hospital
Jeddah, Mecca Region, 21589
About this study
Official title: The Effectiveness of Casein Phosphopeptide Amorphous Calcium Phosphate (MI Varnish) and 5% Sodium Fluoride Plus Xylitol (PreviDent Varnish) on Non Cavitated Interproximal Lesions. Randomised Clinical Trial
Fluoride products are proven to be cost effective in preventing dental caries. Newer Fluoride products have been released in the market with different components that may have an impact on the clinical and radiographic outcome regarding incipient caries management. The objective of the study is to compare the effectiveness of PreviDent and MI varnish to (1.23%) Acidulated phosphopeptide Fluoride (APF) on remineralisation of non-cavitated proximal incipient lesions.
Read the detailed description
The patients will be randomly assigned in three groups by coin toss after obtaining the consent form and filling the questionnaire about file number, gender, socioeconomic status, education and occupation of the parents and their marital status. Group one will receive MI varnish, group two will receive PreviDent varnish, group three will receive 1.23% APF standard Fluoride application. The teeth will be cleaned, plaque will be removed, placement of wedge/separator and teeth will be dried with the aids of light, mouth mirror and dental probe followingInternational Caries Detection and Assessment System (ICDAS) score. The clinical assessment will be conduct during the application visit initial (T1), three months follow up visit (T2) six months follow up visit (T3) and twelve months follow up visit (T3) to evaluate the effectiveness of the different types of Fluoride. The radiographic assessment will be conducted during (T3) and (T4).
- Conditions
- Prevention
- Being tested
- MI Varnish, PreviDent Varnish, 1.23% APF
- Keywords
- caries, interproximal caries, MI varnish, PreviDent varnish, Fluoride, 1.23% APF Fluoride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MI VarnishDrug
Also called GC MI varnish, Recaldent, primary DI number: D6580052651
Application of MI varnish material versus the standard 1.23% APF.
PreviDent VarnishDrug
Also called Colgate PreviDent varnish ,product DI number: 00038341330937
Application of PreviDent Varnish material versus the standard 1.23% APF.
1.23% APFDrug
Also called ZAP fluoride gel, NDC Number: 24794-0102-16
Standard 1.23% APF application
| Study group | Role | What they receive |
|---|---|---|
| MI Varnish Group | Experimental | The teeth will be cleaned, plaque will be removed, placement of wedge/separator and teeth will be dried with the aids of light, mouth mirror and dental probe following ICDAS score. Remineralization protocol, group one will be treated with MI varnish according to the manufacture instructions in first visit and each follow up visits. Receives: Drug: MI Varnish |
| PreviDent Varnish Group | Experimental | The teeth will be cleaned, plaque will be removed, placement of wedge/separator and teeth will be dried with the aids of light, mouth mirror and dental probe following ICDAS score. Group two will receive PreviDent varnish according to the manufacture instructions in the first visit and each follow up visits. Receives: Drug: PreviDent Varnish |
| 1.23% APF Control Group | Active comparator | Regular application of APF for 4 minutes with high volume suction to the whole mouth. Receives: Drug: 1.23% APF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic outcome
Incipient lesions either remained the same or worsened.
Measured: 1 year
Secondary outcomes (1)
Clinical examination
Lesion cavitation
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2019
- Study start1 Jan 2019
- Primary completion29 May 2020 (estimated)
- Study completion1 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Abdulaziz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Narmin Helal, King Abdulaziz University
- Investigators
- Heba J Sabbagh, PHD, Principal investigator, King Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03925740
- Sponsor's protocol ID
- KAUFDNHelal
- Status last verified
- Apr 2020
- First submitted
- 21 Apr 2019
- Last updated
- 9 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Casein Phosphopeptide Amorphous Calcium Phosphate (MI Varnish) and 5% Sodium Fluoride Plus Xylitol (PreviDent Varnish) on Non Cavitated Interproximal Lesions. Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT03925740
- Acronym / sponsor ID
- KAUFDNHelal
- Conditions
- Prevention
- Keywords
- caries, interproximal caries, MI varnish, PreviDent varnish, Fluoride, 1.23% APF Fluoride
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- King Abdulaziz UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 29 May 2020 (estimated)
- Study completion
- 1 Sep 2020 (estimated)
- First posted
- 24 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Fluoride products are proven to be cost effective in preventing dental caries. Newer Fluoride products have been released in the market with different components that may have an impact on the clinical and radiographic outcome regarding incipient caries management. The objective of the study is to compare the effectiveness of PreviDent and MI varnish to (1.23%) Acidulated phosphopeptide Fluoride (APF) on remineralisation of non-cavitated proximal incipient lesions.
Detailed description
The patients will be randomly assigned in three groups by coin toss after obtaining the consent form and filling the questionnaire about file number, gender, socioeconomic status, education and occupation of the parents and their marital status. Group one will receive MI varnish, group two will receive PreviDent varnish, group three will receive 1.23% APF standard Fluoride application. The teeth will be cleaned, plaque will be removed, placement of wedge/separator and teeth will be dried with the aids of light, mouth mirror and dental probe followingInternational Caries Detection and Assessment System (ICDAS) score. The clinical assessment will be conduct during the application visit initial (T1), three months follow up visit (T2) six months follow up visit (T3) and twelve months follow up visit (T3) to evaluate the effectiveness of the different types of Fluoride. The radiographic assessment will be conducted during (T3) and (T4).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MI Varnish Group | Experimental | Drug: MI VarnishThe teeth will be cleaned, plaque will be removed, placement of wedge/separator and teeth will be dried with the aids of light, mouth mirror and dental probe following ICDAS score. Remineralization protocol, group one will be treated with MI varnish according to the manufacture instructions in first visit and each follow up visits. |
| PreviDent Varnish Group | Experimental | Drug: PreviDent VarnishThe teeth will be cleaned, plaque will be removed, placement of wedge/separator and teeth will be dried with the aids of light, mouth mirror and dental probe following ICDAS score. Group two will receive PreviDent varnish according to the manufacture instructions in the first visit and each follow up visits. |
| 1.23% APF Control Group | Active comparator | Drug: 1.23% APFRegular application of APF for 4 minutes with high volume suction to the whole mouth. |
Who may qualify
- Ages
- 7 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Patient is 7-10 mixed dentition
- Patients with any incipient non cavitated posterior proximal caries
- Patients with any incipient non cavitated anterior proximal cariesanterior
- ICDAS Score 1 or 2
Key exclusion criteria (5 listed)
- Any patients with any serious chronic medical problem.
- caries that cross the dentin-enamel junction (DEJ) or enamel discontinuity
- history of proximal restorations
- history of resin infiltrate
- ICDAS score of proximal caries more than two clinically or radiographically.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MI VarnishAlso: GC MI varnish, Recaldent, primary DI number: D6580052651Application of MI varnish material versus the standard 1.23% APF. | Drug | MI Varnish Group |
| PreviDent VarnishAlso: Colgate PreviDent varnish ,product DI number: 00038341330937Application of PreviDent Varnish material versus the standard 1.23% APF. | Drug | PreviDent Varnish Group |
| 1.23% APFAlso: ZAP fluoride gel, NDC Number: 24794-0102-16Standard 1.23% APF application | Drug | 1.23% APF Control Group |
Primary outcome
Radiographic outcome
Time frame: 1 year
Incipient lesions either remained the same or worsened.
1 secondary outcome
Clinical examination
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heba J Sabbagh, PHD principal investigator
King Abdulaziz University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing MI Varnish, PreviDent Varnish and 1.23% APF in people with Prevention, run by King Abdulaziz University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic outcome (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2020.